1. NADA141-135, Approved by FDA
vetsulin'Ulliireinsulinzirl:SIJS!ll1Sioo)
PRODUCT INFORMATION
CAUTION
Federalla'.... resuic1s th;s drug touse by or on the order01 il licensed veterinarian.
INDICATION
velsulin!i (porcine insulinlinc suspension) is indicatedfor thereduction of kyperglycemia and hyperglycemia­
associated clinical signsin dogs and cats ~th diabetes mellitus.
CONTRAINDICATIONS
Dogs andcats knO'.'m to have asystemiC allergy toporkorpork products shouldnotbe treated '.'.'Iln vetsulin~.
vetsulin'! is contraindicated during periods of hypog~ce mia .
WARNINGS
User Safety: For use in animals only. Keep out of the reachof children.Avoid contact ,'lith €}'e s. In case ofcontact,
immediately flush eyes .Yith copiousamounts of water for 15minutes.Accidentalinjection may cause clinical hypo­
glycemia. In case of accldentalinjectron,seek medical attention immediately. Exposure !O product may induce a local
or systemicallergic reaction insensitized individuals.
Animal Safety:O::ners should be advised to observe for signs ofhypoglycemia (see OwnerInformationSheet).
Use of thisproduct, evenat established doses, has been associatedwith hypoglycemia, Afl animalwith signsof hype­
glycemiashould be treated immediately. Glucose should be given orallyor intravenously as dictated by clinicalsigns.
Insulin should be temporarily ':.~thheld and, subsequently, the dosage shouldbe adjusted,if indicated.
AnychangE in insulin should be made cautiously and only under aveterinarian's supel'~sion. Changes in insulin
strength, manufacturer. type, species (animal, human) or method of manufacture (rDNAversus animal·source insulin)
may result in the need fer achange indosage.
Appropriate diagnostic tests should be performed torule out endocrinopathiesin petsthat are difficult to regulate
(e.g., hyperadrenocorticism in dogs and hyperthyroidism in cats).
PRECAUTIONS
Animals presenting ...·,'ith severe ketoacidosis,anor€;.;ia , lethargy, and/or vomiting should be stabilized '.'.'ith short-acting
insulin and appropriate supportive therapyuntil their condition is stabilized.As 'Nith aUinsulinproducts,careful patient
monitoring for hypog~ce mia and h)'pe{g~cemia are essentialto anain andmaintain adequate glycemiccontrol and
prevent associatedcomplications.Overdosage canresult in profoundhypoglycemia and death.Prcgestogens, certain
endocrinopathies, and glucocorticods can have an antagonisticeffect on insulin activity.Intact bitches shouldbe
ovarichy>terectomized, Prog€S lOgen and glucc::orticoid use should be 3'oided
Drug Interactions:
In the USdinicaleffectiveness studies,dogs and cats received various medications ",.hile beingtreated',itn
vetsulin'!: induolJlgantimIcrobials, antivirals, antifungals, antihistamines,analgesics, anesthetics/tranquilizers, diuretics.
bronchodilators, tOrticosterold5 (cats). NSAJDs, thyroid horm~ne supplementation, hyperthYToid medication
(methimazole), Internaland externalparasiticides, anti-emetics, dermatologicaltopicaltreatments and oral
supplements. ophthalmic preparations containingantimicrobials and antiinflammatories, and various vaccine5.
No medication interactions were reported. This drug'.','as not studIed in dogsreceivingcorticosteroids
Reproductive Safety: The safety andeffectiveness of vetsulin! in breeding, pregnant, and lactatingdJgs and cats
has not been eval'.Jated.
Use in puppies and kittens: The safety and effectiveness of '.'elsulin$in puppiesandkittens has not beenevaluated
ADVERSE REACTIONS
Dogs
Inthe field effectiveness andsafety study, 66 dogswere trealed with velsulin', Sixty-t'.'.'odogs ,','ere included inthe
assessment of salety.Hypoglycemia (delined asblood glucose <50 mg/dl)·,~th or without associated clinical signs
occurred in35.5%(22162) of the dogs at varioos times during the study.Clinicalsigns of hypoglycemiawere generaUy
mild in nature (described as weakness, lethargy, stumbling, faUing dO','m, and/ol depression). Disorientation andcollapse
were reported less frequent~ and occurred in 16.1% (10/62)of the dog3.Two dogs had a seizure andone dog died
during the seizure. Although never confirmed. the presumptive diagnosiswas hypoglycemia-induced seizures. Inthe
rest of the dogs, hypoglycemiaresolved with appropriate therapy and adjustments ininsulin dosage.
Seven owners recorded the folh:!lngcbservationsabout the injection site on the home monitOring forms: sV!ollen,
painful, sore, Cind ablebunderthe skin.
The fonowing clinicalobservations occurred in the field studyfollowingtreatment ':!ith vetsulin? and may be
directly attributed to the drug or may be seccndary to the diabetic state or other undedyingconditionsin the dogs:
hematuria, vomiting, diarrhea, pancreatitiS, non-specifichepatopathy/pancreatitis, development of cataracts, and
urinary tract infections.
Cats
In afield effectiveness and safety study, safety data ':!as reported lor78 catsreceiving vetsu)ln~. Hypoglycemia
(defined asblood glucose <SO mg/dL) wasreponedin 61cats(88total incidences). Fiheenof the o::currences
(involving 13cats)were associated'lith clinicalsignsdescribedas lethargy, diarrhea, decreased appetite/anorexia,
vomiting, and h)'Pothermia. One cat had seizures 101l0',;n9accidentaloverdosing by the owner and again duringthe
subsequent dose adjustment period.The cat respcnded to supportive therapy and had no further hypoglycemic
episodes. In al! casesof hypoglycemia, the dinical signs resolved fo.l!o'.~ng symptomatic treatment and/or
dose adjustment.
Polyneuropathy,....as reported in 4cats.Two injectionsite reactions were reported: one as a mildly thickened
subcutaneous tissue reaction andthe second as a mildbruising.
The follo......ingclinicalobservations occurred in the field study foIl0·.1n9 treatment with vetsulin! and may be directly
attributed to the drug or may be secondary to the diabeticstate or other underlying conditions in the cats:vomiting,
lethargy, diarrhea, decreased appetite/anorexia, pancreatitiS, dermalevents, respiratory disease, urinary tract disorder,
renaldisease, dehydration.v!eight loss, polydipSia, polyuria, behavioralchange, and ocular discharge/conjunctivitis.
In asmaller field eHectiveness and safety study, 14 cats were treated '.'lith vetsulin!l. Hypoglycemia,,·.as reported in
6cats (8 totaloccurrences). lethargy not associatedwithhypoglycemia'laSreportedin 4cats (6 total occurrences).
The foHO'.',~ng clinical observations occurred in the fieldstudy following treatmentwith vetsulin!l and may be diredly
attributed 10 the drugormay be secondary tothe diabetic state or otherunderlying conditions in the calS:foul odor
to stool, diarrhea, dull coat, rapid,shallow breathing,stiff gate in rear, gallop rhythm,and pruritus ;th alopecia.
During the 1998-2007period, the following adverse events in 50 cats treated with porcine insulinzincsuspension
were reported to InleNet International and Intel''et Inc.:Death, seizures, lack of effectiveness/dysregulation,
hypoglycemia, aUergic orskin reaction, lethargy,vomiting/diarrhea, injection pain, hyperthermia, nystagmus, PUlPO,
andabnormalbehavior.
To repen adverse reactions, ,,111-800-345-4735,
Additional information about vetsulin1 and diabetes mellituscan be found at 'I',"'·l.vetsulin.ccm
Distributed by: INTERVET INC
Millsboro,DE19966
Made in Germany 01/03
vetsulinis aregistered trademark ofIntervet Inc. or an affiliate
©2008lnteIVet Inc. All rights "se"ed. CA-VETPI·9086CHI2f()8
!ntervet Inc.
PO Box 318, 29160 InteIVet Lane
Millsboro, D.laware19966-0318
USA
Phone: 800 511 5767 ~ Intervetw......·/.intervetusa com ~- Schering'PJough Animal Health
Help your vetsulin®(porcine insulinzincsuspension)
patients make
the transition.
Now approved for use in cats & dogs.
• Charts to help you transition patients to Vetsulin
• Glucose Curve Generator & Worksheet
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;;;:;;..-------­• Treatment Monitoring Sheet
• Administration Guides
• Pet Owner Brochures
• Pet Owner Information Sheet
~er
vetsulin®(porcineinsulin zinc suspension)
Vetsulin Vials
2.5 mLx 10........$54.76
10mL...................$lS.54
Vetsulin Syringes, U-40
O.5mL syringes, box/100.....$23.66
@ Intervet1.0 mL syringes, box/100....$23.66 '1- 5<hering'Plough Animal Health